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MFI™ for Parenteral Drugs
USP Chapter 788 (Particulate Matter in Injections) describes physical tests to be performed for the purpose of enumerating subvisible particles within specific size ranges. Recently the FDA has published a Stimuli Article (reference USPC 30 (6) Pages 2272-2280) demonstrating that advances in apparatus and quality control merit reducing the permissible particle counts within the specified size ranges. Chapter 788 identifies light obscuration and microscopy
USP Chapter 788 (Particulate Matter in Injections) describes physical tests to be performed for the purpose of enumerating subvisible particles within specific size ranges. Recently the FDA has published a Stimuli Article (reference USPC 30 (6) Pages 2272-2280) demonstrating that advances in apparatus and quality control merit reducing the permissible particle counts within the specified size ranges. Chapter 788 identifies light obscuration and microscopy
Aug. 4, 2007